Cidara Therapeutics, Melinta announce publication on ReSTORE trial of rezafungin

Cidara Therapeutics announced the peer-reviewed publication of data from the completed pivotal ReSTORE Phase 3 clinical trial evaluating the efficacy and safety of its once-weekly antifungal candidate rezafungin as a potential treatment for candidemia and invasive candidiasis. The data, published in The Lancet titled, "Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis: a multicentre, double-blind, double-dummy, randomised phase 3 trial," demonstrate the statistical noninferiority of rezafungin dosed once-weekly, versus the current standard of care caspofungin, dosed once-daily. Melinta announced earlier this year that it had acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara. Cidara reported positive topline results from ReSTORE in December 2021. Rezafungin met the primary endpoint for the U.S. Food and Drug Administration New Drug Application submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency Marketing Authorization Application submission of global cure at Day 14. In the study, researchers evaluated one 400 milligram dose of rezafungin for the first week followed by 200 mg of rezafungin dosed once-weekly for up to four weeks in total. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin. The FDA has accepted for filing and granted Priority Review to Cidara’s NDA for rezafungin for the treatment of candidemia and invasive candidiasis. The FDA has assigned a Prescription Drug User Fee Act target action date of March 22, 2023, enabled by rezafungin’s designation as a Qualified Infectious Disease Product and has indicated that the application will be discussed during a scheduled meeting of the Antimicrobial Drugs Advisory Committee on January 24, 2023. Cidara retains the rights to rezafungin in Japan and in addition to licensing the commercial rights to Melinta in the U.S., has licensed the commercial rights in all other geographies to Mundipharma.